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Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00052832
First received: January 24, 2003
Last updated: February 6, 2009
Last verified: November 2004
History of Changes
  Purpose

RATIONALE: Doxercalciferol may improve low blood cell counts and decrease the need for blood transfusions and may be an effective treatment for myelodysplastic syndrome or chronic myelomonocytic leukemia.

PURPOSE: Phase II trial to study the effectiveness of doxercalciferol in treating patients who have myelodysplastic syndrome or chronic myelomonocytic leukemia.


Condition Intervention Phase
Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
 Dietary Supplement: doxercalciferol
 Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Doxercalciferol for the Treatment of Myelodysplastic Syndromes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 2002
Detailed Description:

OBJECTIVES:

  • Determine the response rate of patients with myelodysplastic syndromes or chronic myelomonocytic leukemia treated with doxercalciferol.
  • Determine the toxicity profile of this drug in these patients.
  • Determine the time to progression and overall survival of patients treated with this drug.

OUTLINE: Patients receive oral doxercalciferol daily for 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: Approximately 41 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Morphologically and cytogenetically confirmed myelodysplastic syndromes or chronic myelomonocytic leukemia

    • No more than 20% blasts by bone marrow biopsy

  • Must meet at least 1 of the following criteria:

    • Anemia

      • Hemoglobin less than 11 g/dL over a 2-month period
    • Thrombocytopenia
    • Neutropenia

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics

Hepatic

  • ALT and AST less than 1.5 times upper limit of normal
  • Bilirubin less than 3 mg/dL
  • Albumin greater than 3.0 g/dL

Renal

  • Creatinine clearance greater than 50 mL/min
  • No history of hypercalcemia
  • No renal stones within the past 5 years

Cardiovascular

  • No clinically significant heart failure
  • No uncontrolled hypertension

Pulmonary

  • No clinically significant pulmonary failure

Other

  • Not pregnant
  • Fertile patients must use effective contraception during and for 6 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 4 weeks since prior growth factor or cytokine therapy

Chemotherapy

  • At least 8 weeks since prior cytotoxic chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • Concurrent transfusion support allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00052832

Locations
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
National Cancer Institute (NCI)
Investigators
Study Chair: Mark B. Juckett, MD University of Wisconsin, Madison
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00052832     History of Changes
Other Study ID Numbers: CDR0000258754, WCCC-HO-02403
Study First Received: January 24, 2003
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
chronic myelomonocytic leukemia
previously treated myelodysplastic syndromes
secondary myelodysplastic syndromes
 de novo myelodysplastic syndromes
atypical chronic myeloid leukemia
myelodysplastic/myeloproliferative disease, unclassifiable

Additional relevant MeSH terms:
Leukemia
Leukemia, Myelomonocytic, Chronic
Myelodysplastic Syndromes
Preleukemia
Leukemia, Myelomonocytic, Acute
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Bone Marrow Diseases
 Hematologic Diseases
Precancerous Conditions
1 alpha-hydroxyergocalciferol
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 16, 2013